OT: Embryo-like stem cells enter first human trial
NATURE NEWS BLOG 14 Feb 2013 | 16:53 GMT | Posted by Davide Castelvecchi | Category: Biology & Biotechnology, Health and medicine
Posted on behalf of David Cyranoski
It will be the first clinical study to put induced pluripotent stem (iPS) cells into humans — and where more fitting than Japan, where Shinya Yamanaka garnered a Nobel prize for last December for showing how to take bodily cells and return them to an embryo-like pluripotent state.
Masayo Takahashi of the Center for Developmental Biology in Kobe just cleared the second and, observers say, most difficult hurdle in starting her iPS cell trial to treat age-related macular degeneration, a condition that affects the retina and can lead to blindness.
On Wednesday an institutional review board (IRB) at the Institute for Biomedical Research and Innovation (IBRI), which is going to sponsor the trial, gave conditional approval. The team need now only notify the IRB of the final results of some pre-clinical safety trials now underway (see story in Japanese).
Having already received IRB approval at her home institution, Takahashi can now move toward the final step before patient recruitment: getting health ministry approval. She’s expected receive that in time for starting the trials during this fiscal year, ending March 2014.
The trial will enroll 6 patients above 50 years of age. The researchers will remove damaged pigment epithelium and then implanting a small sheet of new epithelium. The sheet will be created by coaxing iPS cells, created from the patient’s body cells, to become epithelium cells.
Takahashi says that apart from a small risk of damage from the surgical procedure itself (sticking a needle in the eye) and a much smaller risk of the stem cells themselves going awry, preclinical studies suggest the procedure to be safe.
The clinical trial, meant to demonstrate the safety of the procedure in humans, is not expected to reverse the damage of macular degeneration, but researchers hope that it will at least slow its progress.
Elk, the thing is that they are more than a year behind ACT's trials, and they are not expected to reverse the damage, just hopefully slow down it's progress, inwhich case we already have drugs on the market doing that. And in ACT's trials patients have shown improved vision, and in Maurie Hill's case it seems to have stopped deterioration in her treated eye, this along with her one year examine coming this July, inwhich the results could be a huge for ACT, and her, too.